# K820777: Mini-Micro Arthroscopic Scapel

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: May 12, 1982 after 50 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 28, 2012 · Class II · Z-1914-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Source page: https://510kreport.com/device/K820777
Methodology: https://510kreport.com/methodology